Status:
RECRUITING
The Effect of Different Low-Level Tragus Stimulation Parameters On Autonomic Nervous System Function
Lead Sponsor:
University of Oklahoma
Conditions:
Atrial Fibrillation
Heart Failure, Diastolic
Eligibility:
All Genders
21-90 years
Phase:
NA
Brief Summary
Low level transcutaneous vagus nerve stimulation (LLTS) involves delivery of electrical impulses transcutaneously at the auricular branch of vagus nerve and it has been shown to have anti-inflammatory...
Eligibility Criteria
Inclusion
- Male and female patients older than 21 year old
- Healthy volunteers free from diagnosis of AF, heart failure, coronary artery disease or diseases that affect the autonomic nervous system.
- Patients with Paroxysmal Atrial Fibrillation
- Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)
Exclusion
- Recent (\<6 months) stroke
- Recent (\<6 months) myocardial infarction
- Heart failure (NYHA class III or IV)
- Left ventricular ejection fraction \<50%
- Recurrent vaso-vagal syncopal episodes
- Unilateral or bilateral vagotomy
- Pregnancy or breast feeding
- Uncontrolled diabetes or hypertension
- Inability or unwillingness to understand and/or sign informed consent
- Any serious disease that affects autonomic nervous system function
- Any medications that affect autonomic nervous system function
Key Trial Info
Start Date :
November 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04682704
Start Date
November 30 2021
End Date
February 1 2025
Last Update
February 21 2024
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104